Apparatus for treating pelvic floor disorders and related methods of use

ABSTRACT

A method of optimizing the electrical stimulation of a bladder of a patient including selecting a first subset of electrodes from a set of electrodes positioned adjacent to a set of nerves associated with the bladder. The set of electrodes may include one or more electrodes, each of which may be configured to deliver electrical stimulation pulses generated by a stimulator device to the nerves. The method may further include delivering an electrical stimulation pulse through the selected first subset of electrodes and recording at least one parameter of the electrical stimulation pulse after receiving patient feedback.

PRIORITY

This application is a Continuation Application of U.S. patentapplication Ser. No. 13/961,302, filed Aug. 7, 2013, now U.S. Pat. No.8,886,321, which claims the benefit of priority of U.S. ProvisionalApplication No. 61/680,961, filed on Aug. 8, 2012, all of which areincorporated by reference herein in their entireties.

FIELD

The present disclosure relates generally to systems for treating pelvicfloor disorders. More particularly, embodiments of the disclosure relateto neuromodulation systems for treating an overactive bladder andmethods of optimizing their use.

BACKGROUND

Clinicians use medical devices alone or in combination with drug therapyand surgery to treat medical conditions. Depending on the condition,medical devices can be surgically implanted or connected externally tothe patient receiving treatment. For some conditions, medical devicesprovide the best, and sometimes the only, therapy to restore anindividual to a more healthy condition. These conditions may includevarious pelvic floor disorders such as, for example, overactive bladder(OAB) syndrome.

Overactive bladder (OAB) syndrome is often expressed as frequent andspontaneous activation or inhibition of the detrusor muscle, which maymanifest in the form of urge incontinence, urinary frequency syndrome,or chronic urinary retention. Acute conditions, such as, for example,bladder stones, may cause a temporary or “acute” onset of overactivebladder syndrome. Once the stones are passed from the urinary tract,urinary urgency subsides. Chronic conditions such as, for example,interstitial cystitis, may cause persistent overactive bladder syndromethat does not improve with time.

For those with either acute or chronic overactive bladder syndrome whohave been unsuccessful with more conservative treatments, such as drugsor behavioral modification, treatments such as neural stimulation can beeffective. The neural stimulation treatment procedure is based on mildelectrical stimulation of nerves, for example, the sacral nerves and thepudendal nerve, which may inhibit preganglionic neurons, therebysuppressing detrusor overactivity. This treatment employs aneuromodulation system including an implanted lead that is attached to amedical device implanted in the patient receiving treatment. The neuralstimulation therapy may be controlled using an external device or may beautomated.

While existing neuromodulation systems for treating overactive bladdersyndrome may be effective for their intended purpose, it is desirable toimprove methods of using such systems so that they may adjust forefficacy and patient tolerance levels to the electrical stimulation.Additionally and/or alternatively, it is desirable to provide a systemthat may be intuitive to use so that it may be used by patients in anoutpatient setting with limited or no medical supervision.

SUMMARY OF THE DISCLOSURE

Embodiments of the present invention are directed to systems and methodsfor optimizing use of neuromodulation systems for treating a bladder ofa patient.

A method of optimizing the electrical stimulation of a bladder of apatient is disclosed. The method may include selecting a first subset ofelectrodes from a set of electrodes positioned adjacent to nervesassociated with the bladder, the set of electrodes including one or moreelectrodes. The set of electrodes may be configured to deliverelectrical stimulation pulses generated by a stimulator device to thenerves. The method may further include delivering at least oneelectrical stimulation pulse through the first subset of electrodes andrecording at least one parameter associated with the at least oneelectrical stimulation pulse after receiving patient feedback.

In various embodiments, the method may include one or more of thefollowing additional features: wherein receiving patient feedbackincludes receiving patient feedback in response to a sensationassociated with the at least one electrical stimulation pulse; whereinrecording the at least one parameter of the at least one electricalstimulation pulse includes recording an amplitude of the at least oneelectrical stimulation pulse; further including increasing an amplitudeof the at least one electrical stimulation pulse until receiving patientfeedback based on patient tolerance; further including selecting asecond subset of electrodes different from the first subset ofelectrodes; further including delivering at least one electricalstimulation pulse through the second subset of electrodes; furtherincluding recording at least one parameter of the at least oneelectrical stimulation pulse delivered through the second subset ofelectrodes after receiving patient feedback; further including comparingthe recorded at least one parameter of the at least one electricalstimulation pulse of the first subset of electrodes to the recorded atleast one parameter of the at least one electrical stimulation pulse ofthe second subset of electrodes to determine the relative efficacy ofeach electrode included in the first subset of electrodes and the secondsubset of electrodes; further including testing or exhausting allcombinations of the electrodes included in the set of electrodes andadjusting delivery of therapy by electrical stimulation to the nerves;wherein delivering at least one electrical stimulation pulse through thefirst subset of electrodes includes delivering the at least oneelectrical stimulation pulse for a predetermined period of time; furtherincluding determining a level of efficacy of electrical stimulationthrough the first subset of electrodes over the predetermined period oftime based on patient feedback; further including recording the level ofefficacy of electrical stimulation for the first subset of electrodes;further including: selecting a second subset of electrodes differentfrom the first subset of electrodes, delivering at least one electricalstimulation pulse through the second subset of electrodes for apredetermined period of time, determining a level of efficacy ofelectrical stimulation through the second subset of electrodes over thepredetermined period of time based on patient feedback, and recordingthe level of efficacy of electrical stimulation for the second subset ofelectrodes; further including sensing one or more physiologic signalsassociated with the bladder; and further including adjusting the levelof efficacy based on the one or more physiologic signals.

A method of treating a patient is also disclosed. The method may includedelivering therapy by electrical stimulation through a set of electrodespositioned adjacent to nerves associated with a bladder of the patient.The set of electrodes may include one or more electrodes. The electrodesmay be configured to deliver electrical stimulation pulses generated bya stimulator device to the nerves. The method may further includereceiving data regarding a time of voiding based on patient feedback.

In various embodiments, the method may include one or more of thefollowing additional features: wherein the data includes a date ofvoiding, and further includes recording the data in a log, such as anelectronic voiding log; and further including modifying therapy byelectrical stimulation based on the data in the electronic voiding log.

A system for treating a bladder of a patient is also disclosed. Thesystem may include a stimulator device configured to generate electricalstimulation pulses and a set of electrodes coupled to the stimulatordevice via at least one lead. The set of electrodes may include one ormore electrodes. Each electrode included in the set of electrodes isconfigured to deliver the electrical stimulation pulses to nervesassociated with the bladder. The system may further include a controllerin communication with the stimulator device. The controller may have aprocessor configured to (i) cause a selected subset of the set ofelectrodes to deliver at least one electrical stimulation pulse and (ii)record at least one parameter of the electrical stimulation pulsedelivered by the selected subset of electrodes after receiving patientfeedback.

In various embodiments, the method may include one or more of thefollowing additional features: wherein the controller is configured to(i) cause a second selected subset of the set of electrodes to deliverat least one stimulation pulse and (ii) record at least one parameter ofthe electrical stimulation pulse delivered by the second selected subsetof the at least one electrode; wherein the controller is configured toreceive patient feedback; and wherein the controller is configured toadjust parameters of the electrical stimulation based on the patientfeedback.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate exemplary embodiments of thepresent disclosure and together with the description, serve to explainthe principles of the disclosure.

FIG. 1 illustrates a neuromodulation system including an implantedstimulator device and an external receiving device, according to anexemplary embodiment of the present disclosure;

FIG. 2 is a schematic diagram of the stimulator device, according to anexemplary embodiment of the present disclosure;

FIG. 3 is a schematic diagram of the receiving device, according to anexemplary embodiment of the present disclosure;

FIG. 4 is a flow diagram illustrating a method of determining aneffective electrode configuration for delivery of therapy by electricalstimulation, according to an exemplary embodiment of the disclosure;

FIG. 5A is a representation of a graphical user interface (GUI) of thereceiving device at step 58 of the method illustrated in FIG. 4,according to an embodiment of the disclosure;

FIG. 5B is a representation of a graphical user interface (GUI) of thereceiving device at step 62 of the method illustrated in FIG. 4,according to an exemplary embodiment of the disclosure;

FIG. 6 is a table illustrating the exemplary results captured by themethod exemplified in FIG. 4, according to an exemplary embodiment ofthe disclosure;

FIG. 7 is a flow diagram illustrating a method of determining aneffective electrode configuration for delivery of therapy by electricalstimulation, according to another exemplary embodiment of thedisclosure;

FIG. 8A is a representation of a graphical user interface (GUI) of thereceiving device at step 96 of the method illustrated in FIG. 7,according to an embodiment of the disclosure;

FIG. 8B is a representation of a graphical user interface (GUI) of thereceiving device at step 92 of the method illustrated in FIG. 7,according to an exemplary embodiment of the disclosure;

FIG. 8C is a representation of a graphical user interface (GUI) of thereceiving device at steps 90 and 98 of the method illustrated in FIG. 7,according to an exemplary embodiment of the disclosure;

FIG. 9 is a table illustrating exemplary results captured by the methodexemplified in FIG. 7, according to an exemplary embodiment of thedisclosure;

FIG. 10 is a flow diagram illustrating a method of monitoring voiding bya patient with overactive bladder syndrome, according to an exemplaryembodiment of the disclosure;

FIG. 11 is a representation of a graphical user interface (GUI) of thereceiving device at step 128 of the method illustrated in FIG. 10,according to an exemplary embodiment of the disclosure;

FIG. 12 is a flow diagram illustrating a method of monitoring voiding bya patient with overactive bladder syndrome, according to anotherexemplary embodiment of the disclosure;

FIG. 13A is a representation of a graphical user interface (GUI) of thereceiving device at step 150 of the method illustrated in FIG. 12,according to an exemplary embodiment of the disclosure; and

FIG. 13B is a representation of a graphical user interface (GUI) of thereceiving device at step 154 of the method illustrated in FIG. 12,according to an exemplary embodiment of the disclosure.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Whenever possible, the same reference numbers will be usedthroughout the drawings to refer to same or like parts.

Generally described, the present disclosure relates to systems andmethods for treating pelvic floor disorders. The term “pelvic floor”refers to the group of muscles associated with the pelvic organs (e.g.,bladder, rectum, and reproductive organs). Pelvic floor disorders, whichare characterized by weakened or injured pelvic muscles, include urinaryincontinence, fecal incontinence, and sensory and emptying abnormalitiesof the urinary tract including bladder overactivity.

Embodiments of the present disclosure relate to methods of optimizingneuromodulation systems for treating bladder overactivity. Bladderoveractivity is characterized by involuntary contractions of thedetrusor muscle during bladder filling, which may result in a suddenurge to urinate. Neuromodulation systems relate broadly to systems fordelivering electrical stimulation to a neural network associated withthe bladder for treatment of bladder overactivity. It should beunderstood that the systems and methods described herein may be used totreat pelvic floor conditions other than bladder overactivity such as,for example, fecal incontinence, chronic idiopathic constipation,interstitial cystitis, and chronic inflammation of the bladder walls.The systems and methods may also be used to treat other conditions ofthe body, including conditions that require electrical stimulation totreat pressure ulcers (e.g. multiple sclerosis or spinal cord injuries).

FIG. 1 illustrates an exemplary neuromodulation system 20. System 20includes an implantable stimulator device 22 that is configured todeliver electrical stimulation therapy to a patient 10. Stimulatordevice 22 may be an implantable pulse generator and may deliver therapyto patient 10 in the form of electrical stimulation pulses. In theexemplary embodiment, stimulator device 22 is implanted proximate thespine 16 in a region on the posterior hip. Alternatively, stimulatordevice 22 may be implanted in a more medial tissue region, e.g., in thelower abdomen. As shown in FIG. 1, a proximal end 24 a of a lead 24 iselectrically coupled to stimulator device 22 in a conventional mannerand extends distally from stimulator device 22 towards bladder 12.Distal end 24 b of lead 24 may be implanted adjacent to nerves 18associated with bladder 12 (e.g., sacral nerves). Disposed generallynear distal end 24 b of lead 24 are a plurality of electrodes 26 a-26 d.Electrodes 26 a-26 d may be configured to receive electrical signalsindicative of one or more physiological signals and/or deliverelectrical stimulation to nerves 18. Although the depicted embodimentincludes four electrodes 26 a-26 d disposed on a distal end 24 b of onelead 24, those of ordinary skill in the art will readily recognize thata greater or lesser number of electrodes may be disposed on one or moreleads without departing from the scope of the disclosure.

Neuromodulation system 20 may further include a sensing element 28,which may be separate from stimulator device 22. Although the depictedembodiment includes only one sensing element 28, those of ordinary skillin the art will readily recognize that a plurality of sensing elements28 may be included without departing from the scope of the disclosure.Sensing element 28 may include any suitable sensor known in the art. Forexample, sensing element 28 may include an electrical, mechanical, orchemical sensor. In one embodiment, sensing element 28 may be placedadjacent to the walls of bladder 12 or within the bladder walls. It willbe understood that, as used here, bladder walls include the external orinternal walls of bladder 12 so that sensing element 28 may be locatedinside or outside of bladder 12. Sensing element 28 may be configured tosense one or more physiological signals including, but not limited to,electrical activity, chemical signaling, or biological changes such as,for example, voiding. Sensing element 28 may transmit sensory data via alead (not shown) and/or wirelessly to stimulator device 22.

FIG. 2 is a schematic of stimulator device 22. Stimulator device 22includes an input/output apparatus 25, a telemetry apparatus 21, and aprocessor apparatus 23. Input/output apparatus 25 may include at leastone input/output device 25 a such as, for example, an adapterelectrically coupled to proximal end 24 a of lead 24. In certainembodiments, sensing element 28 may be connected to stimulator device 22via a lead (not shown). In those embodiments, input/output apparatus 25may include an input device (e.g., adapter) electrically coupled to thelead. Telemetry apparatus 21 may be any known device such as, forexample, an RF telemetry head, configured to communicate wirelessly withan external receiving device 30. In some embodiments, telemetryapparatus 21 may additionally communicate with sensing element 28.Processor apparatus 23 may include a microprocessor (μP) or any otherprocessor 23 a. The processor apparatus 23 may be configured to receivesignals from input/output apparatus 25 and/or telemetry apparatus 21.Processor apparatus 23 may be configured to process signals to transmitto receiving device 30 via telemetry apparatus 21 or electrodes 26 a-26d via lead 24. In other embodiments, stimulator device 22 may notinclude a telemetry apparatus 21. For example, neuromodulation may beperformed without telemetry apparatus 21 if stimulator device 22 hasother sources of electrical contact, signal transmission, or signalprocessing, for example.

Stimulator device 22 may further include a memory 27. Memory 27 may beany one or more of a variety of types of internal or external storagemedia, e.g., RAM, ROM, EPROM(s), EEPROM(s), that provide a storageregister for data storage, such as in the fashion of an internal storagearea of a computer, and can include volatile memory or nonvolatilememory. Memory 27 may be configured to store one or more algorithms andtherapeutic programs executable by processor 23 to control delivery oftherapy by electrical stimulation. In some embodiments, memory 27 mayalso store physiologic data received from sensing element 28.

Receiving device 30, as illustrated generally in FIG. 1 and depictedschematically in FIG. 3, may be a handheld electronic control device.Receiving device 30 may be configured to generate control signals andwirelessly transmit those signals to stimulator device 22 to control thetherapy by electrical stimulation. In some embodiments, receiving device30 may be configured to wirelessly receive physiologic data from sensingelement 28.

Receiving device 30 may include a telemetry apparatus 31, an inputapparatus 35, a processor apparatus 36, and an output apparatus 38.Telemetry apparatus 31 may be any known device such as, for example, anRF telemetry head configured to wirelessly communicate with stimulatordevice 22 and/or sensing element 28. Input apparatus 35 may include aninput device 34 such as, for example, a numeric keypad, a directionalkeypad, an alphabetic keypad, an alphanumeric keypad, a QWERTY keypad,or any other keypad configuration incorporating one of these layouts orportions thereof. Processor apparatus 36 may include a microprocessor(μP) or any other processor 40. Processor apparatus 36 may be configuredto receive input signals from input apparatus 35 and process outputsignals sent to output apparatus 38 or telemetry apparatus 31. Outputapparatus 38 may include a display 32 such as, for example, an LCDdisplay. In some embodiments, display 32 may be a touch screen display.

Receiving device 30 may further include a memory 42. Memory 42 may beany one or more of a variety of types of internal or external storagemedia such as, without limitation, RAM, ROM, EPROM(s), EEPROM(s), andthe like that provide a storage register for data storage, such as inthe fashion of an internal storage area of a computer, and may includevolatile memory or nonvolatile memory. As a general matter, memory 42may have stored therein a graphical user interface (GUI) software 44, atherapeutic program 48, and a number of algorithms 46 that areexecutable on processor 40. GUI software 44 may be executed to displayon display 32 one or more prompts requesting input from the patientand/or a third party (e.g., clinician). Program 48 may be executed tocontrol delivery of therapy by electrical stimulation. As will bedescribed below, algorithms 46 may be executed to optimize delivery oftherapy by electrical stimulation, adjusting for efficacy and/orindividual patient tolerance levels. Additionally and/or alternatively,algorithms 46 may be executed to monitor the efficacy of the therapyover the duration of treatment by recording efficacy observations overtime. It is contemplated that at least certain algorithms 46 and/orportions of the algorithms may be stored in memory 27 and executed byprocessor 23 of stimulator device 22. It is further contemplated thatalgorithms 46 may be fully-automated, partially-automated, or fullycontrolled by the patient and/or third party (e.g., clinician). It willbe understood that, as used here, clinician refers to any medicalpersonnel having knowledge sufficient to treat and/or assist in thetreatment of urinary conditions.

FIG. 4 illustrates a method for optimizing delivery of therapy byelectrical stimulation. The exemplary method 50 illustrated in FIG. 4may optimize delivery of therapy by a titration procedure andaccordingly adjust therapy parameters such as, for example, an effectiveelectrode configuration. This method may be preferred for patientshaving an acute overactive bladder condition. However, it is understoodthat the method may also be used for patients with chronic and/ornon-acute overactive bladder conditions. In the exemplary method 50,processor 40 may determine an effective electrode configuration bymethodically increasing the amplitude of electrical stimulation pulsesdelivered by a particular electrode configuration until receivingfeedback from the patient or clinician. Processor 40 may then switch tothe next electrode configuration in the test until all theconfigurations have been exhausted. In this manner, the method mayeliminate the need for the clinician and/or patient to press “up” or“next” on receiving device 30 during the testing procedure.

As illustrated in FIG. 4, the exemplary method 50 may begin when acorresponding algorithm 46 is initiated (step 52). Algorithm 46 may beinitiated at various times over the duration of treatment. For example,algorithm 46 may be initiated after stimulator device 22 has beenimplanted within the patient's body 10, at a first programming session,or at any subsequent follow-up visit, if appropriate. Algorithm 46 maybe initiated at a follow-up visit when, for example, it is believed thatthe position of one or more of electrodes 26 a-26 d has changed, whenaccommodations to the therapy are required, or during any other suitabletype of event. In some embodiments, the clinician, either in person orremotely, may initiate algorithm 46. Alternatively, algorithm 46 may beinitiated by the patient, for example, under the direction of theclinician.

Upon initiation of algorithm 46 (step 52), an electrode configuration isselected (step 54). Electrode configuration, as used here, refers to aset of one or more electrodes. The electrode configuration may beselected from the plurality of electrodes 26 a-26 d on lead 24. Eachelectrode configuration may be distinguished by the number of electrodesand/or, in some embodiments, the polarities of each electrode of theelectrode configuration. When an electrode configuration is selected,stimulator device 22 may be configured such that no electrical energy istransmitted to the selected electrode configuration.

Next, processor 40 may be configured to transmit a control signal tostimulator device 22 to increase at least one parameter associated withthe electrical stimulation pulse. Examples of such parameters mayinclude, but are not limited to, amplitude of the electrical stimulationpulse, pulse polarity, pulse width, pulse shape, pauses orirregularities of pulses, frequency of stimulation, duty cycle, or theperiodicity of stimulation. There may be gradual changes or suddenchanges in such parameters over time. In the exemplary embodiment,processor 40 is configured to transmit a control signal to stimulatordevice 22 to increase an amplitude of the electrical stimulation pulsedelivered by the selected electrode configuration. Processor 40 may beconfigured to increase the amplitude of the electrical stimulation pulseby a predetermined increment (step 56). The increment by which theamplitude is increased may be managed by the clinician. For example, thepredetermined increment may be determined by the clinician prior toinitiation of the algorithm (step 52). In the exemplary embodiment, theamplitude is increased by 0.1 mA; however, the amplitude may beincreased by any other value.

Processor 40 may then be configured to display on display 32 a userprompt. The user prompt may be a health care question to, for example,determine if the patient feels a sensation based on the increase in theamplitude of electrical stimulation (step 58). For example, a prompt 70may be: “Do you feel a sensation?”, as illustrated in FIG. 5A. In someembodiments, display 32 may include input graphical elements providingsuggested responses. In the exemplary embodiment, the patient may beprovided with graphical elements 72 a, 72 b providing “yes” or “no”response options. Patient feedback to prompt 70 may be entered via inputdevice 34 by either the clinician or the patient. If the patientindicates feeling a sensation, the amplitude may be recorded and storedin memory 42 of receiving device 30 (step 60). If the patient indicatesnot feeling a sensation in response to prompt 70, the amplitudedelivered by the selected electrode configuration may be increased untilthe patient indicates feeling a sensation. As an alternative torequiring patient input, processor 40 may wait 5 or 10 seconds, or anyother appropriate time interval, before transmitting a signal tostimulator device 22 to increase the amplitude by the predeterminedincrement. The time interval may be shortened at low amplitude levels.In other embodiments, this determination may not be required.

After the patient indicates feeling a sensation, processor 40 may beconfigured to display on display 32 another user prompt. The user promptmay be a health care question to, for example, determine if thesensation is tolerable (step 62). For example, a prompt 77 may be: “Isthe stimulation OK?”, as illustrated in FIG. 5B. In the exemplaryembodiment, the patient may also be provided with graphical elements 76a, 76 b providing “yes” or “no” response options. Patient feedback toprompt 74 may be entered via input device 34 by either the clinician orthe patient. If the patient indicates that the sensation is tolerable,the amplitude of electrical stimulation delivered by the selectedelectrode configuration may be increased until the patient indicatesthat the electrical stimulation is not tolerable (step 64). Once thepatient indicates that the sensation is not tolerable, the amplitude maybe recorded (step 66). Processor 40 may then switch to another electrodeconfiguration and repeat the method until all electrode configurationshave been exhausted (step 68).

In some embodiments, the method may be rendered more efficient byinitially increasing the amplitude by substantially large increments(e.g., 0.5 mA) until the patient indicates that the sensation is nottolerable. Processor 40 may then generate and transmit a control signalto stimulator device 22 to reduce the amplitude delivered by theselected electrode configuration by, for example, 0.1 mA, until thepatient indicates that the stimulation is tolerable. Alternatively,processor 40 may generate and transmit a control signal to stimulatordevice 22 to reset the amplitude delivered by the selected electrodeconfiguration to the last setting and increase the amplitude by, forexample, 0.1 mA, until the patient indicates that the stimulation is nottolerable. Additionally and/or alternatively, a clinician may manage thenumber of electrode configurations that are tested. For example, theclinician may prioritize or limit the electrode configurations to, forexample, adjacent electrodes that are tested. In other embodiments, theclinician may initiate a contrast algorithm by which processor 40 runsthe algorithm for a suspected “ideal” electrode configuration and aconfiguration expected to be substantially different to compare results.

After all of the electrode configurations have been tested, the resultsmay be captured in a table for review by the clinician (step 69). Anexemplary table 78 is illustrated in FIG. 6. Table 78 may list, forexample, the electrode configurations, including the polarities of eachelectrode (wherein an anode is referenced as “A” and a cathode isreferenced as “C”). In addition, for each tested electrodeconfiguration, table 78 may include the recorded amplitude at which asensation was felt and the recorded amplitude at which the patientindicated that the electrical stimulation was intolerable. Otherparameters may also be included on table 78 such as, for example, theduration of stimulation, the frequency of stimulation, and the width ofthe electrical stimulation pulse. The clinician may then use table 78 todetermine the most effective electrode configuration for deliveringtherapy by electrical stimulation. Criteria used for the determinationmay include, but is not limited to, the electrode configuration thatgenerates the best efficacy measurement or lowest amplitude that meets apredetermined efficacy measurement threshold. The clinician may theninput the parameters that identify the most effective electrodeconfiguration into therapeutic program 48 to deliver therapy byelectrical stimulation through the set of electrodes that meets theclinician's criteria.

In some embodiments, processor 40 automatically inputs these parametersinto program 48. In those embodiments, processor 40 may be configured todisplay on display 32 a prompt requesting the clinician to inputcriteria by which to determine the most effective electrodeconfiguration. Processor 40 may then add those parameters to therapeuticprogram 48.

FIG. 7 illustrates another method for optimizing delivery of therapy byelectrical stimulation. The exemplary method 80, illustrated in FIG. 7,may optimize delivery of therapy by a titration procedure to adjusttherapy parameters including, for example, an effective electrodeconfiguration and parameters associated with the electrodeconfiguration. This method may be preferred for patients having chronicoveractive bladder conditions. In accordance with this embodiment, aneffective electrode configuration may be determined by testing anelectrode configuration for a predetermined period of time until all thecombinations of electrodes 26 a-26 d are exhausted. Processor 40 maythen recommend or, alternatively, automatically program therapy byelectrical stimulation for a patient through the set of electrodes thatmeets the clinician's efficacy criteria. This method may ease theclinician's service burden by giving patients more control over managingtheir therapy.

As illustrated, the method for optimizing delivery of therapy byelectrical stimulation may begin when algorithm 46 associated with themethod is initiated (step 82). In one embodiment, algorithm 46 may beinitiated after stimulator device 22 has been implanted within thepatient's body 10. It is contemplated that, in some circumstances,algorithm 46 may be initiated at a first programming session, or anysubsequent follow-up visit, if appropriate. As discussed above,algorithm 46 may be initiated at a follow-up visit when, for example, itis believed that the position of one or more of the electrodes haschanged, where accommodations to the therapy are required, or any othersimilar event. In some embodiments, the clinician, either in person orremotely, may initiate algorithm 46. In doing so, the clinician mayinput one or more parameters into the algorithm. For example, theclinician may program a maximum current for delivering electricalstimulation, an expected ideal electrode configuration, the number ofelectrode configurations to be tested, the amplitude of electricalstimulation delivered by the selected configurations, or any otherrelevant parameter (e.g., pulse width, frequency of pulses, duty cycles,or periodicity of stimulation). In some embodiments, the parameters maybe determined by first performing the method illustrated in FIG. 4. Inparticular, the method illustrated in FIG. 4 may be performed todetermine an ideal configuration, which may then be inputted for useduring the method illustrated in FIG. 7.

Upon initiation of algorithm 46, an electrode configuration may beselected (step 84). The electrode configuration may be selected from theplurality of electrodes 26 a-26 d on lead 24. Each electrodeconfiguration may be distinguished by the number of electrodes and, insome embodiments, the polarities of each electrode of the electrodeconfiguration. When an electrode configuration is selected, stimulatordevice 22 may be configured such that no electrical energy istransmitted to the selected electrode configuration. Next, receivingdevice 30 may transmit a control signal to stimulator device 22 todeliver therapy by electrical stimulation through the selected electrodeconfiguration for a predetermined period of time (step 86). In oneexample, the predetermined period of time may be a week, however, itwill be understood that the predetermined period may be any suitablelength of time.

After processor 40 has determined that the predetermined period haslapsed (step 88), processor 40 may prompt the patient to evaluate thetherapy. For example, processor 40 may be configured to display ondisplay 32 a prompt 110: “How do you rate this week's therapy?”, asillustrated in FIG. 8C. The patient may also be provided with graphicalelements providing the suggested responses. In the exemplary embodiment,the patient may be provided with graphical elements 112 a-112 eproviding a rating scale of 1-5. Patient feedback to prompt 110 may beentered via input device 34 by either the clinician or the patient.

Additionally and/or alternatively, processor 40 may receive signals fromsensing element 28 and may record the data transmitted from sensingelement 28. This data may include, but is not limited to, voidingfrequency, bladder volume, bladder pressure, and/or any otherphysiologic data. Such data may be recorded separately or may beanalyzed with the patient feedback to generate an automatic patientrating. The patient may then be provided with the option to terminatethe method for optimizing delivery of therapy by electrical stimulation(step 92) or switch to the next electrode configuration (step 94) andrepeat the method until all electrode configurations have beenexhausted. To do so, processor 40 may be configured to display ondisplay 32 a prompt 106, as illustrated in FIG. 8B, and may request ayes-or-no response as shown by graphical elements 108 a, 108 b.

In some embodiments, the patient may have the option to shorten theduration of therapy for an electrode configuration. In particular,processor 40 may be configured to display on display 32 a prompt overthe course of the predetermined period, which may provide the patientwith an option to skip the electrode configuration. An exemplary prompt102 may be, for example, “Skip this configuration?”, as illustrated inFIG. 8A, and may request a yes-or-no response as shown by graphicalelements 104 a, 104 b. Input to prompt 102 may be entered via inputdevice 34 by either the clinician or the patient. If the patientrequests to skip the configuration, processor 40 may be configured todisplay on display 32 a prompt 110 requesting the patient to rate thetherapy (step 98), before switching to the next electrode configuration(step 94).

After the desired electrode configurations have been tested, the resultsmay be captured in a table for review by a clinician (step 99). Anexemplary table is illustrated in FIG. 9. Table 112 may include, forexample, the electrode configurations, including the polarities of eachelectrode (wherein an anode is referenced as “A” and a cathode isreferenced as “C”). Table 112 further includes, for each electrodeconfiguration, the amplitude at which a sensation was felt and thepatient rating. Table 112 may also include other relevant parametersincluding, for example, pulse width, frequency of pulse, periodicity oftherapy, and duration of therapy. The physician may then use table 112to determine the most effective electrode configuration for deliveringtherapy by electrical stimulation. Criteria used for the determinationmay include, but is not limited to, the electrode configuration thatgenerates the best efficacy measurement or lowest amplitude that meets apredetermined efficacy measurement threshold. The clinician may thenprogram the therapeutic program to deliver therapy by electricalstimulation through the set of electrodes that meets the clinician'scriteria. In alternate embodiments, processor 40 may automaticallymodify the diagnostic program to include such parameters and deliver thetherapeutic electrical stimulation through the set of electrodes thatmeets the clinician's criteria.

FIG. 10 illustrates an exemplary method for monitoring voiding duringthe treatment of overactive bladder. Exemplary method 120 may beemployed to capture the date and time of patient input of voiding so asto generate an electronic voiding log, which may improve the patient'streatment records and may ease the clinician's service burden by givingpatients more control over their therapy.

As illustrated, exemplary method 120 may begin when algorithm 46associated with the method is initiated (step 122). In one embodiment,algorithm 46 may be initiated after stimulator device 22 has beenimplanted within the patient's body 10. It is contemplated that, in somecircumstances, algorithm 46 may be initiated at a first programmingsession.

Once algorithm 46 has been initiated, processor 40 may be configured tomonitor an electronic voiding log stored in memory 42, including voidingentries (Step 124). Voiding entries refers to entries including the dateand time of voiding by the patient. In some embodiments, the type ofentry may correlate with the function of the bladder. For example, theinput may indicate if the patient has voided voluntarily, oralternatively, if the patient has experienced leaking. Such data may beinputted manually through input device 34 or may be automaticallydetected via sensing element 28. When input is manually entered, thevoiding entry may be confirmatory or may be merged with voiding entriesthat are recorded automatically.

As shown in FIG. 10, exemplary method 120 may include deliveringelectrical stimulation therapy (step 126). The electrical stimulationtherapy may be optimized and delivered based on the methods describedabove. After delivering the therapy, processor 40 may compare signalsreceived from sensing element 28 to the electronic voiding log todetermine if the electronic voiding log has been modified and an entryregarding voiding has been made (step 128). In particular, processor 40may analyze data received from sensing element 28 indicative of patientvoiding and compare such data to the electronic log stored in memory 42.If an entry has not been made, processor 40 may be configured to displayon display 32 prompts reminding the patient to enter data regarding thedate and time of voiding. For example, processor 40 may be configured todisplay on display 32 a prompt 132, as illustrated in FIG. 11. If theentry has been made, processor 40 may record the information (step 130).Entries in the electronic voiding log may be analyzed, and an average ofthe entries and/or trends in the entries may be presented to the patientand/or clinician on receiving device 30 at a desktop communicator, aclinician programmer, or a remote programmer.

FIG. 12 illustrates another exemplary method for monitoring voidingduring the treatment of overactive bladder. As discussed above, themethod may include initiating the algorithm (step 142) and monitoringthe electronic voiding log (step 144) before and during delivery oftherapy (step 146) by electrical stimulation. After delivery of therapy,processor 40 may be configured to display on display 32 a prompt to thepatient requesting an input. For example, processor 40 may be configuredto display on display 32 a prompt 158, as illustrated in FIG. 13A,reminding the patient to enter data regarding the date and time ofvoiding. If the entry has been made, processor 40 may record theinformation (step 152) and may further determine the if the patient iscomfortable over the duration of treatment (step 154). For example,processor 40 may be configured to display on display 32 one or morequestions designed to determine the patient's comfort levels. Thesequestions may be yes-or-no questions, such as the exemplary promptillustrated in FIG. 13B, or may require a rating that is analyzed byprocessor 40. Such questions may, for example, request that the patientidentify if they are comfortable; rate their comfort level; identify ifthey perceive the urge to urinate has subsided or if the voidingfrequency has increased or decreased; identify if they feel theelectrical stimulation and, if so, identify if the sensation ofstimulation is tolerable; identify if the perception of stimulationchanges whether they are sitting or standing; and identify if they feelpain. If it is determined that the patient is comfortable, the processormay resume monitoring the voiding log. If it is determined that thepatient is not comfortable, processor 40 may then modify the therapy(step 156). The modification of the therapy may include modifying theelectrode configuration, and may be automatically executed by stimulatordevice 22 or receiving device 30. In other embodiments, receiving device30 may alert a clinician, who may make such modifications by a clinicianprogrammer or remotely by a desktop communicator.

In additional and/or alternative embodiments, the clinician may be ableto program the duration and start time of the therapy by electricalstimulation. As therapy by electrical stimulation may be morecomfortable during different times of the day or at different levels ofactivity, programming the duration and start time of the therapy byelectrical stimulation may increase patient satisfaction over theduration of the treatment. As such, the clinician may be able to programa duration and set of start times, and the patient may be able to selectthe duration and/or the preferred start time. In some embodiments, thedevice may display a go button that initiates the automatic delivery oftherapy. In other embodiments, the device may display a delay buttonthat delays the automatic delivery of therapy. In some additionalembodiments, the patient and/or clinician may be able to adjust forvariations in the time zone or adjust for daylight savings. In yet otherembodiments, the receiving device or a remote desktop communicator mayautomatically adjust start time based on a GPS or other knowledge.

In other embodiments, data entry into logs may further includeenvironmental data about a patient that may affect a patient's response.Environmental data may include, but is not limited to, for example, foodor drink consumption, the amount or quality of sleep, medicationsconsumed, time of day, or exercise history. Such log entries couldreflect patterns of environmental data or recent data history, forexample, food consumption in the past 24 hours.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. A method of optimizing the electrical stimulationof a bladder of a patient, the method comprising: selecting a firstsubset of electrodes from a set of electrodes positioned adjacent tonerves associated with the bladder, wherein each electrode of the set ofelectrodes is configured to deliver electrical stimulation pulsesgenerated by a stimulator device to the nerves; delivering at least oneelectrical stimulation pulse through the first subset of electrodes;sensing a physiological response via a sensor positioned on an externalbladder wall; and recording at least one parameter associated with theat least one electrical stimulation pulse delivered through the firstsubset of electrodes after receiving patient feedback and thephysiological response.
 2. The method of claim 1, wherein delivering atleast one electrical stimulation pulse through the first subset ofelectrodes includes delivering the at least one electrical stimulationpulse for a predetermined period of time.
 3. The method of claim 2,further including: determining a level of efficacy of electricalstimulation through the first subset of electrodes over thepredetermined period of time based on patient feedback.
 4. The method ofclaim 1, wherein recording at least one parameter includes recording alevel of efficacy of electrical stimulation for the first subset ofelectrodes.
 5. The method of claim 4, further including: adjusting thelevel of efficacy based on the one or more physiologic signals.
 6. Themethod of claim 1, wherein sensing a physiological response includessensing at least one of voiding frequency, bladder volume, and bladderpressure.
 7. The method of claim 1, further including: selecting asecond subset of electrodes different from the first subset ofelectrodes; and delivering at least one electrical stimulation pulsethrough the second subset of electrodes, wherein a magnitude of the atleast one electrical stimulation pulse delivered through the firstsubset of electrodes is equal to a magnitude of the at least oneelectrical stimulation pulse delivered through the second subset ofelectrodes.
 8. The method of claim 7, further including: recording atleast one parameter associated with the at least one electricalstimulation pulse delivered through the second subset of electrodesafter receiving patient feedback.
 9. The method of claim 8, furtherincluding: comparing the recorded at least one parameter associated withthe at least one electrical stimulation pulse of the first subset ofelectrodes to the recorded at least one parameter associated with the atleast one electrical stimulation pulse of the second subset ofelectrodes to determine the relative efficacy of each of the firstsubset of electrodes and the second subset of electrodes.
 10. The methodof claim 1, further including: repeating the selecting, delivering,sensing, and recording steps with all combinations of electrodes of theset of electrodes.
 11. The method of claim 1, wherein the sensorpositioned on an external bladder wall includes at least one of achemical, an electrical, and a mechanical sensor.
 12. A method ofoptimizing the electrical stimulation of a bladder of a patient, themethod comprising: selecting a first subset of electrodes from a set ofelectrodes positioned adjacent to nerves associated with the bladder,wherein each electrode of the set of electrodes is configured to deliverelectrical stimulation pulses generated by a stimulator device to thenerves; delivering at least one electrical stimulation pulse through thefirst subset of electrodes; recording at least one parameter associatedwith the at least one electrical stimulation pulse delivered through thefirst subset of electrodes after receiving patient feedback; andrepeating the selecting, delivering, and recording steps with allcombinations of electrodes of the set of electrodes.
 13. The method ofclaim 12, further including: selecting a second subset of electrodesdifferent from the first subset of electrodes; and delivering at leastone electrical stimulation pulse through the second subset ofelectrodes, wherein a magnitude of the at least one electricalstimulation pulse delivered through the first subset of electrodes isequal to a magnitude of the at least one electrical stimulation pulsedelivered through the second subset of electrodes.
 14. The method ofclaim 13, further including: recording at least one parameter associatedwith the at least one electrical stimulation pulse delivered through thesecond subset of electrodes after receiving patient feedback.
 15. Themethod of claim 14, further including: comparing the recorded at leastone parameter associated with the at least one electrical stimulationpulse of the first subset of electrodes to the recorded at least oneparameter associated with the at least one electrical stimulation pulseof the second subset of electrodes to determine the relative efficacy ofeach of the first subset of electrodes and the second subset ofelectrodes.
 16. The method of claim 12, further including: sensing aphysiological response via a sensor positioned on an external bladderwall.
 17. The method of claim 16, wherein sensing a physiologicalresponse includes sensing at least one of voiding frequency, bladdervolume, and bladder pressure.
 18. The method of claim 16, wherein thesensor positioned on an external bladder wall includes at least one of achemical, an electrical, and a mechanical sensor.
 19. The method ofclaim 12, wherein recording of at least one parameter includes recordinga level of efficacy of electrical stimulation for the first subset ofelectrodes.
 20. A method of optimizing the electrical stimulation of abladder of a patient, the method comprising: selecting a first subset ofelectrodes from a set of electrodes positioned adjacent to nervesassociated with the bladder, wherein each electrode of the set ofelectrodes is configured to deliver electrical stimulation pulsesgenerated by a stimulator device to the nerves; delivering at least oneelectrical stimulation pulse through the first subset of electrodes;sensing a physiological response via a sensor positioned on an externalbladder wall; and recording at least one parameter associated with theat least one electrical stimulation pulse delivered through the firstsubset of electrodes after receiving patient feedback and thephysiological response wherein the sensor positioned on an externalbladder wall includes at least one of a chemical, an electrical, and amechanical sensor.